Importance Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited. Objective To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD. Design, Setting, and Participants The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019. Interventions In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%). Main Outcomes and Measures The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs. Results Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar. Conclusions and Relevance Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure. Trial Registration Netherlands Trial Register Identifier: NTR3764.

中文翻译：

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对比剂增强计算机断层扫描前不预水化与碳酸氢钠预水化在预防慢性肾病成人对比剂后急性肾损伤中的作用

重要性 多年来，通过预补液预防 3 期慢性肾病 (CKD) 患者的造影后急性肾损伤一直是标准治疗。然而，该组需要预水化的证据是有限的。目的 评估 3 期 CKD 患者在使用碘造影剂之前不进行预防性预水化的肾脏安全性。设计、设置和参与者 Kompas 试验是一项在荷兰 6 家医院进行的多中心、非劣效性、随机临床试验，其中 523 名 3 期 CKD 患者以 1:1 的比例随机接受不预水化或预水化 250 mL在 2013 年 4 月至 2016 年 9 月期间进行选择性对比增强计算机断层扫描之前，在 1 小时内输注 1.4% 碳酸氢钠。最终随访于 2017 年 9 月完成。分析了 2018 年 1 月至 2019 年 6 月的数据。 干预措施 总共 262 名患者被分配到无预水化组，261 名患者被分配到接受预水化。对 505 名患者 (96.6%) 的主要终点进行了分析。主要结果和测量 主要终点是对比剂给药后 2 至 5 天血清肌酐水平与基线相比的平均相对升高（非劣效性界限是血清肌酐水平升高小于 10%）。次要结局包括造影剂给药后 2 至 5 天造影后急性肾损伤的发生率、造影剂给药后 7 至 14 天肌酐水平的平均相对增加、需要透析的急性心力衰竭和肾衰竭的发生率以及医疗保健费用。结果 在随机分组的 554 名患者中，523 名被纳入意向治疗分析。中位（四分位距）年龄为 74（67-79）岁；336 人（64.2%）为男性，187 人（35.8%）为女性。与基线相比，对比剂给药后 2 至 5 天肌酐水平的平均 (SD) 相对增加在未预水化组中为 3.0% (10.5)，在预水化组中为 3.5% (10.3)（平均差异，0.5；95% CI ，-1.3 到 2.3；对于非劣效性，P < .001）。11 名患者 (2.1%) 发生造影后急性肾损伤，其中无预水化组 262 名中的 7 名 (2.7%) 和预水化组 261 名中的 4 名 (1.5%)，导致相对风险为 1.7 (95%) CI，0.5-5.9；P = .36）。没有患者需要透析或发生急性心力衰竭。亚组分析显示没有证据表明治疗组和预先定义的亚组之间存在统计学上的相互作用。预水化组每位患者的平均水化成本为 119 欧元（143.94 美元），而未预水化组为 0 欧元（0 美元）（P < .001）。其他医疗保健费用类似。结论和相关性 在接受对比增强计算机断层扫描的 3 期 CKD 患者中，停止预水化不会危及患者的安全。这项研究的结果支持不进行预水化的选择，作为一种安全且具有成本效益的措施。试验注册荷兰试验注册标识符：NTR3764。其他医疗保健费用类似。结论和相关性 在接受对比增强计算机断层扫描的 3 期 CKD 患者中，停止预水化不会危及患者的安全。这项研究的结果支持不进行预水化的选择，作为一种安全且具有成本效益的措施。试验注册荷兰试验注册标识符：NTR3764。其他医疗保健费用类似。结论和相关性 在接受对比增强计算机断层扫描的 3 期 CKD 患者中，停止预水化不会危及患者的安全。这项研究的结果支持不进行预水化的选择，作为一种安全且具有成本效益的措施。试验注册荷兰试验注册标识符：NTR3764。